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NCT04523129 · ClinicalTrials.gov registry record · Phase 3
ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
A Phase 3 study of Dry Eye Disease, sponsored by Novaliq.
- Completed
- Registry status
- Phase 3
- Development phase
- 834
- Enrollment target
- 20
- Study locations
NCT04523129: Completed Phase 3 study of Dry Eye Disease, sponsored by Novaliq.
NCT04523129 is a Phase 3 study of Dry Eye Disease that has completed, run by Novaliq. The registered enrollment target is 834 participants, above the 230-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (263% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04523129, a Phase 3 study of Dry Eye Disease, has completed, sponsored by Novaliq.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 834 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).
Primary Outcome
Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).
Conditions Studied
Interventions
- DRUG CyclASol topical ocular, eye drops
- DRUG Vehicle topical ocular, eye drops
Study Locations (20)
California
- CYS-004 Investigational Site - Los Angeles
- CYS-004 Investigational Site - Newport Beach
- CYS-004 Investigational Site - Santa Ana
Indiana
- CYS-004 Investigational Site - Carmel
- CYS-004 Investigational Site - Indianapolis
Massachusetts
- CYS-004 Investigational Site - Andover
- CYS-004 Investigational Site - Raynham
Missouri
- CYS-004 Investigational Site - Kansas City
- CYS-004 Investigation Site - Kansas City
North Carolina
- CYS-004 Investigational Site - Raleigh
- CYS-004 Investigational Site - Shelby
Arizona
- CYS-004 Investigational Site - Phoenix
Colorado
- CYS-004 Investigational Site - Colorado Springs
Florida
- CYS-004 Investigational Site - Fort Lauderdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 834 participants |
| Start Date | 2020-12-05 |
| Est. Completion | 2021-10-08 |
| Phase | Phase 3 |
What the finished NCT04523129 record still lists
NCT04523129 is an interventional study that assigns participants to a tested intervention. The registered 834 participants enrollment target is mid-sized for trials with a published cap, above the 230-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (263% higher).
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which CyclASol topical ocular, eye drops is the first listed.
NCT04523129 names 20 study sites across 14 states, led by California, Indiana, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04523129 about?
NCT04523129 is a clinical study titled "ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)". The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).
What is the current status of trial NCT04523129?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 834 participants. The study started on 2020-12-05. Estimated completion is 2021-10-08.
What conditions does trial NCT04523129 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT04523129?
The interventions under investigation include: CyclASol topical ocular, eye drops (DRUG), Vehicle topical ocular, eye drops (DRUG).
Who is sponsoring clinical trial NCT04523129?
This trial is sponsored by Novaliq, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04523129 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04523129's enrollment target sits among peer trials
834 3rd of 33 higher than 31 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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